NL-OMON33219已完成不适用
A double-blind, randomized, placebo-controlled, five-way cross-over interaction trial to investigate the inhibitory effect of olanzapine on a THC-induced increase on the Positive and Negative Syndrome Scale - The effect of olanzapine on a THC-induced increase on the PANSS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age between 18 and 45 (extremes included)
- •Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes included)
- •Mild cannabis user for at least one year, defined as use of cannabis no more than once a week (as an average in the last year)
- •Ability to refrain from using cannabinoids (other than the THC used in the study) from at least two weeks prior to the first treatment period till the end of the follow-up periods
- •Willing to give written informed consent to participate in the study and to comply with the study procedures
排除标准
- •Clinically significant (history of) psychiatric illness (including substance abuse)
- •Clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, endocrine or neurological disease as determined by medical history, physical examination, ECG or laboratory test results
- •Family history (first-degree relatives) of relevant psychiatric disorders and/or family history (second-degree relatives) of psychotic disorders
- •Participation in a clinical study within the past three months
- •Participation in four or more clinical studies in the past twelve months
- •Positive urine screen for recreational drugs, i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, or MDMA. THC will be tested as well; since volunteers are cannabis users, subjects with a positive THC urine test will be tested again and have to be found THC-negative before the first study day. Subjects with a positive drug test on a study day, including THC, will be excluded
- •Exposure to any medication, including over-the-counter medication and herbal agents, 14 days prior to randomization (except paracetamol)
- •Exposure to prescription medication within 30 days prior to screening
- •Positive testing for Hepatitis B or C, or HIV-1 or HIV-2
- •Smokes more than four cigarettes per day
- •Unable or unwilling to refrain from alcohol, starting 24 hours before each study day until the end of the study day
- •Unable or unwilling to refrain from smoking on study days
- •Unable or unwilling to refrain from xanthine (i.e. caffeine) intake on study days
- •Unable or unwilling to refrain from quinine (bitter drinks in general, i.e. tonic, grapefruit juice) from 14 days before dosing until discharge
- •Unable or unwilling to refrain from heavy physical exercise 24 hours before study days
- •Unable or unwilling to maintain a regular day/night rhythm during the study
- •Donation (or loss) of more blood, including this study, than allowed by the regulations of the Dutch blood bank (Sanquin)
- •Relevant (history of) drug allergy or hypersensitivity to drugs
- •Subject is the investigator or any sub-investigator, or a subordinate of the investigator or any sub-investigator
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, five parallel group study investigating the efficacy and safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naïve and treated patients with Type 2 diabetes with insufficient glycemic control (study includes an open-label metformin treatment arm)EUCTR2006-002311-27-CZBoehringer Ingelheim Pharmaceuticals, Inc.375
招募中
不适用
A randomized, double-blind, placebo-controlled, first-in-human phase 1 study evaluating safety, tolerability, and pharmacokinetics of single ascending doses of SOL-116 (a humanized monoclonal anti-BSSL antibody) in healthy subjects and patients with rheumatoid arthritis.rheumatoid arthritis (RA)10003816NL-OMON56208ipum AB72
已完成
不适用
A randomized, double-blind, placebo controlled, first in human study to investigate the safety, tolerability, and pharmacokinetic and pharmacodynamic response of SLN360 in subjects with elevated lipoprotein (a)atherosclerosisNL-OMON55119Silence Therapeutics plc18
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, five parallel groups study investigating the efficacy and safety of BI 1356 BS (1mg, 5mg and 10mg administered orally once daily) over 12 weeks as add-on therapy in patients with type 2 diabetes and insufficient glycaemic control despite metformin therapy, including an open-label glimepiride treatment arm.Patients with type 2 diabetesMedDRA version: 8.1 Level: PT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependentEUCTR2005-004597-24-GBBoehringer Ingelheim Limited375
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, five parallel groups study investigating the efficacy and safety of BI 1356 BS (1mg, 5mg and 10mg administered orally once daily) over 12 weeks as add-on therapy in patients with type 2 diabetes and insufficient glycaemic control despite metformin therapy, including an open-label glimepiride treatment arm.Patients with type 2 diabetesMedDRA version: 8.1Level: PTClassification code 10012613EUCTR2005-004597-24-SEBoehringer Ingelheim AB500